Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K113759 |
Device Name |
AVAIRA (ENFILCON A) CONTACT LENS |
Applicant |
COOPERVISION, INC. |
6150 Stoneridge Mall Road |
Suite 370 |
Pleasanton,
CA
94588
|
|
Applicant Contact |
KARIN GASTINEAU |
Correspondent |
COOPERVISION, INC. |
6150 Stoneridge Mall Road |
Suite 370 |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
KARIN GASTINEAU |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2011 |
Decision Date | 04/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|